Last Review Date: 09/05/2023

Date of Origin: 09/05/2023                                         

Dates Reviewed: 09/2023

1. Length of Authorization

After the initial hospital administration of three step-up titration doses, coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Talvey 3 mg/1.5 mL solution for injection in a single-dose vial: 3 vials per week
• Talvey 40 mg/1 mL solution for injection in a single-dose vial: 3 vial per week

2. Max Units (per dose and over time) [HCPCS Unit]:
   • Titration: 12 billable units (3 mg) on day one, 36 billable units (9 mg) on day four and 160 billable units (40 mg) on day seven
   • Maintenance: 160 billable units (40 mg) weekly thereafter

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Prescribers are enrolled in the TECVAYLI-TALVEY REMS^® program; AND
• Used as continuation therapy following inpatient administration of all the step-up doses; AND
• Patient had an absence of unacceptable toxicity while on inpatient administration of step-up titration doses; AND

Universal Criteria ¹

• Patient does not have an active infection, including clinically important localized infections; AND
• Prophylaxis for infection will be followed according to local guidelines; AND

• Patient does not have active CNS involvement or clinical signs of meningeal involvement of multiple myeloma; AND

• Patient has not had an allogenic stem cell transplant within the previous six months or an autologous stem cell transplant within the previous 12 weeks; AND
• Patient weight and signs of oral and skin toxicity will be monitored at baseline and periodically during therapy; AND

Multiple Myeloma † ‡ Ф ^1-5

• Used as single-agent therapy; AND
• Patient has relapsed or refractory disease; AND
• Patient has received at least four (4) prior therapies, including a proteasome inhibitor (e.g., bortezomib, etc.), an immunomodulatory agent (e.g., lenalidomide, thalidomide, etc.) and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab, etc.)

† FDA Approved Indication(s); ‡ Compendia Approved Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe oral toxicity and weight loss, serious life-threatening infections, severe cytopenias, severe dermatologic toxicity, hepatotoxicity, neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), cytokine release syndrome (CRS), etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J3055 – Injection, talquetamab-tgvs, 0.25 mg; 1 billable unit = 0.25 mg (Effective 04/01/2024)
• J9999 – Not otherwise classified, antineoplastic drugs (Discontinue use on 04/01/2024)
• C9163 – Injection, talquetamab-tgvs, 0.25 mg; 1 billable unit = 0.25mg (Discontinue use on 04/01/2024)

NDC:

• Talvey 3 mg/1.5 mL solution for injection in a single-dose vial: 57894-0469-xx
• Talvey 40 mg/1 mL solution for injection in a single-dose vial: 57894-0470-xx

7. References

1. Talvey [package insert]. Horsham, PA; Janssen Biotech, Inc.; August 2023.  Accessed August 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for talquetamab. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2023.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma Version 3.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed August 2023.
4. BGM Durie, J-L Harousseau, J S Miguel, et al on behalf of the International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia.  Sep; 20(9):1467-73.
5. Schinke CD, Touzeau C, Minnema MC, et al. Pivotal phase 2 MonumenTAL-1 results of talquetamab (tal), a GPRC5DxCD3 bispecific antibody (BsAb), for relapsed/refractory multiple myeloma (RRMM). Journal of Clinical Oncology 2023 41:16_suppl, 8036-8036.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A